NCT02926625

Brief Summary

Fevers in childhood are common and usually self-resolve. In sub-Saharan Africa, when a febrile child presents to a community health worker (CHW), the child is assessed for malaria, pneumonia, and diarrhea, and other danger signs, according to WHO guidelines for integrated Community Case Management (iCCM) of childhood illnesses. In the cases where 1) there are no danger signs present, and 2) malaria, pneumonia, and diarrhea have been ruled out, the World Health Organization (WHO) recommends that all children be reassessed in 3 days. It is hypothesized that health outcomes for these cases will be equivalent if the CHW advises to come back in 3 days only if symptoms have not resolved. In order to assess this hypothesis, a two-arm cluster-randomized, community-based non-inferiority trial in Southern Nations, Nationalities and People's Regional State (SNNPR) in Southwest Ethiopia will be conducted to assess the non-inferiority of CHW-advised systematic follow-up on day 3 compared to conditional follow-up for non-severe febrile illness in children age 2 to 59 months, in which no cause of fever can be identified and where danger signs are absent.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,179

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

1 year

First QC Date

October 3, 2016

Last Update Submit

January 16, 2018

Conditions

Fever

Keywords

Unspecific feverEthiopiaiCCMCHWHEW

Outcome Measures

Primary Outcomes (1)

  • Treatment failure

    Proportion of children with non-severe febrile illness who, after initial evaluation by a HEW using iCCM algorithm, are not treated for malaria, pneumonia, or diarrhea and who subsequently decline clinically (defined as death, hospitalization, or the development of one or more danger signs).

    Day 7

Secondary Outcomes (5)

  • Illness classification among children with unresolved illness

    Day 7

  • Proportion of caregivers who present to HEWs for the follow-up visit on Day 3

    Day 3

  • Proportion of caregivers who spontaneously re-present to HEWs

    Day 0-7

  • Secondary treatment

    Day 0-7

  • Hospital admission rate

    Day 0-7

Other Outcomes (1)

  • Caregiver and HEW acceptability of systematic and conditional follow-up

    Day 0-28

Study Arms (2)

Conditional follow-up

ACTIVE COMPARATOR

Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should have a conditional follow-up visit, ie. only to come back for re-assessment after 2 days if the child still has fever or is sick. This is in line with national IMNCI guidelines.

Behavioral: Conditional follow-up

Systematic follow-up arm

EXPERIMENTAL

Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should come back for a systematic follow-up visit after 2 days, even if the child has recovered.

Behavioral: Systematic follow-up

Interventions

Systematic follow-upBEHAVIORAL

Febrile children without a diagnosable illness and without danger signs do not need to return to the HEW unless they are still sick, as over 90% of fevers resolve by themselves. HEW advice and procedures * Children with unclassified fever should come back for re-assessment after 2 days only if the child still has fever or is sick * Children who are getting worse should come back immediately or at any time for a re-assessment * All children who come back for re-assessment, regardless of when they come back, should have a full assessment of their condition again. * HEW should fill out a loose child assessment form * If child still has fever and a negative rapid diagnostic test for malaria (mRDT), the HEW should refer the child to the nearest health centre.

Systematic follow-up arm
Conditional follow-upBEHAVIORAL

Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should have a conditional follow-up visit, i.e. only to come back for re-assessment after 2 days if the child still has fever or is sick. This is in line with national IMNCI guidelines.

Also known as: control arm
Conditional follow-up

Eligibility Criteria

Age2 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Non-severe febrile illness that is classified by HEW as unspecific fever

You may not qualify if:

  • Malaria, pneumonia, diarrhoea diagnosis
  • Symptoms requiring referral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ethiopia

Awasa, Southern Nations, Nationalities, and Peoples' Region, Ethiopia

Location

Related Publications (3)

  • Funk T, Kallander K, Abebe A, Alfven T, Alvesson HM. 'I also take part in caring for the sick child': a qualitative study on fathers' roles and responsibilities in seeking care for children in Southwest Ethiopia. BMJ Open. 2020 Aug 20;10(8):e038932. doi: 10.1136/bmjopen-2020-038932.

    PMID: 32819953DERIVED

  • Kallander K, Alfven T, Funk T, Abebe A, Hailemariam A, Getachew D, Petzold M, Steinhardt LC, Gutman JR. Universal versus conditional day 3 follow-up for children with non-severe unclassified fever at the community level in Ethiopia: A cluster-randomised non-inferiority trial. PLoS Med. 2018 Apr 17;15(4):e1002553. doi: 10.1371/journal.pmed.1002553. eCollection 2018 Apr.

    PMID: 29664899DERIVED

  • Kallander K, Alfven T, Workineh AA, Hailemariam A, Petzold M, Getachew D, Barat L, Steinhardt LC, Gutman JR. Universal Versus Conditional Third Day Follow-Up Visit for Children With Nonsevere Unclassified Fever at the Community Level in Ethiopia: Protocol for a Cluster Randomized Noninferiority Trial. JMIR Res Protoc. 2018 Apr 12;7(4):e99. doi: 10.2196/resprot.9780.

    PMID: 29650505DERIVED

Related Links

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Karin Kallander, MSc, PhD

    Malaria Consortium

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2016

First Posted

October 6, 2016

Study Start

December 1, 2015

Primary Completion

November 30, 2016

Study Completion

May 1, 2017

Last Updated

January 18, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

ET(1)